Quality Engineer II

ABOUT HepQuant is a clinical laboratory with headquarters in Denver and a CLIA-accredited lab in Aurora, Colorado. HepQuant develops minimally invasive, blood-based quantitative tests that measure liver health. Our tests deliver information about liver cell function and portal-systemic shunting, attributes of liver disease that are associated with clinical outcomes.

Results may be used by a physician in conjunction with clinical evaluation and other tests to aid clinical management

JOB DUTIES

HepQuant is seeking a dedicated and motivated individual to be responsible for providing quality assurance and engineering support for clinical and commercial In-Vitro Diagnostics; maintaining, and improving the Quality Management System (QMS) process and methods; and ensuring alignment with all applicable FDA, CLSI, Euro-pean IVDR/MDR, and ISO requirements i.e., IEC 62304, ISO 13485/14971/13408, 21 CFR parts 4; 820; 210; 211, ISPE GAMP 5, while utilizing metrics to continually improve quality processes and efficiency.

This position re-ports to the Quality Director.

Primary Duties and Responsibilities

1. Validations & Qualification

• Plan, develop, and execute, validations plans, protocols and reports. Equipment and infrastructure qualifications: Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for manufacturing equipment, utilities, and software.
• Perform Process Validation and Test Method Validations (TMV) to ensure manufacturing processes yield consistent, defect-free IVD products.
• Execute software and computer system validation (CSV) relevant to automated IVD equipment and Laboratory Information Management Systems.

2. Investigations & CAPA

• Lead technical investigations into product non-conformances, customer complaints, and out-of-specification (OOS) results.
• Utilize structured root cause analysis (RCA) tools such as 5 Whys, Fishbone diagrams, and Fault Tree Analysis.
• Initiate, manage and verify the effectiveness of Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues.

3. Regulatory Compliance & Quality Systems

• Ensure strict adherence to ISO 13485 (Quality Management Systems for Medical Devices) and cGMP (current Good Manufacturing Practices).
• Maintain compliance with the European Union In Vitro Diagnostic Regulation (IVDR 2017/746) requirements.
• Apply ISO 14971 risk management principles, creating and updating Product/Process Failure Mode and Effects Analysis (PFMEA).
• Assist in internal audits and host external regulatory or notified body inspections.

Secondary Duties and Responsibilities

1. Design Controls & Product Lifecycle

• Lead quality activities during the transfer of new IVD products from R&D into routine commercial manufacturing.
• Participate in design development and ensure correct design controls are applied: inputs, outputs, verification, and validation strategies, and perform design transfer
• Maintain and update product Risk Management Files (RMF) in accordance with ISO 14971, linking design risks to process mitigation.
• Evaluate and approve engineering change orders (ECOs) for design or material modifications, ensuring no adverse impact on IVDR compliance or product performance.

2. Supplier Quality Management

• Conduct technical evaluations, risk assessments, and quality audits of critical raw material and com-ponent suppliers
• Monitor supplier quality metrics, issue Supplier Corrective Action Requests (SCARs), and lead collaborative investigations into supplier-related defects.
• Establish and update sampling plans, inspection protocols, and test methods for incoming components using statistical standards like ANSI/ASQ Z1.4.

Mandatory Duties and Responsibilities

1. Quality Assurance and Feedback

• Notifying QA of any potential complaints, nonconformities, defects, or product feedback received
• Initiation of issues or corrective action(s) to prevent nonconformities relating to the product, process, and Quality System
• Identification and recording of product quality problems

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Chemical), Life Sciences, or a related technical discipline.
• 3 to 5+ years of progressive quality engineering or quality assurance experience within the medical device or IVD industry.
• Deep understanding of ISO 13485, cGMP, FDA 21 CFR Part 820, and EU IVDR.
• Proven ability to author validation protocols and perform root cause analysis investigations. Proficiency with statistical analysis software (e.g., Minitab) and electronic Quality Management Systems (eQMS) is highly preferred.
• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt are strong assets
• Proficiency with statistical software such as MATLAB, Minitab, etc.

Key Attributes

• Commitment to HepQuant Vision and Values
• Hands-on work: ability to compile own reports, studies, data
• Detail oriented, able to work individually, while also proving their ability to work collaboratively with colleagues, and teammates to create a results-driven, team-oriented environment
• Demonstrates a strong professional work ethic, while striving to meet personal and organization performance goals.
• Excellent written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization
• Professional demeanor and ability to interact with persuasiveness and confidence
• Ability to function as a strong member of a highly motivated and integrated team

Work Environment & Physical Demands

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The employee must occasionally lift and/or move up to 25 pounds (lifting boxes, files, etc.) Specific vision abilities required by this job include close vision, color differentiation, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is required to sit, stand, walk, talk and hear. perception and ability to adjust focus.

While performing the duties of this job, the employee is required to sit, stand, walk, talk and hear.

Classification: Salaried, Exempt

Location: Denver, CO -On Site Required

Travel: Position may require up to 10% travel via airplane, car, and overnight stays.

Benefits

Medical, Dental, Vision, Short and Long-Term Disability and AD&D, Life Insurance, 401(k) with company match, profit sharing program.

Apply online through LinkedIn. No phone calls, please. Note: no third-party recruiters will be enlisted for this search.

• HepQuant is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.